Intensive Motor Training After Perinatal Stroke to Enhance Walking

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Alberta
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01773369
First received: November 30, 2012
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

Early childhood injuries such as perinatal (around birth) stroke are devastating because the child lives with the problem for life, typically close to a normal lifespan. One 'opportunity' presented by a brain injury early in life compared to later in adulthood is that the young brain is much more plastic (malleable) and receptive to interventions. This is particularly true for neural circuits that are still under development. We will test the hypothesis that early (<2 yr old), intensive leg training will improve walking more than no training or training at >2 yr old. We will further determine the changes induced by training in motor and sensory pathways.


Condition Intervention
Perinatal Stroke
Behavioral: Early leg training
Behavioral: Delayed leg training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intensive Motor Training After Perinatal Stroke to Enhance Walking

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Change in Gross Motor Function Measure - 66 (GMFM-66) from baseline [ Time Frame: Pre baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months and at 4 years of age ] [ Designated as safety issue: No ]
    This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), monthly measures will occur thereafter for 6 months, then one final assessment when the child turns 4 years old, for a total of 9 measures.


Secondary Outcome Measures:
  • Change in kinematics and forces during treadmill walking from baseline [ Time Frame: Pre baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), then after each of the training/delay periods, for a total of 5 measures.

  • Change in tendon reflexes from baseline [ Time Frame: Pre baseline, 3 months, 6 months and at 4 years of age ] [ Designated as safety issue: No ]
    The patellar tendon reflexes will be induced by tapping the left and right tendon using a reflex hammer. The response in leg muscles will be recorded with surface electromyography. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.

  • Change in transcranial magnetic stimulation from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ] [ Designated as safety issue: Yes ]
    Transcranial magnetic stimulation (TMS) is a non-invasive way to activate brain cells. A single or double pulse is applied over the motor area of the brain (feels like a tap to the head), and the response is measured in leg muscles using electromyography. The safety concern is that people who are prone to seizures or have implants in their head should not have TMS. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old for a total of 5 measures.

  • Change in somatosensory evoked potentials from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ] [ Designated as safety issue: No ]
    We will use surface electrical stimulation to stimulate a nerve at the ankle and record the activity generated in the brain using electroencephalography (EEG). Surface EEG electrodes will be placed on the head. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.

  • Change in activity monitored at home from baseline [ Time Frame: Pre baseline, 3 months, 6 months, at 4 years of age ] [ Designated as safety issue: No ]
    The child will wear a small activity monitor on each ankle for 3 days, so that we can determine how active the child is at home. Two measures will occur within two weeks prior to beginning training/delay phase (called pre baseline and baseline), after each of the training/delay periods, then a final measure when the child turns 4 yr old, for a total of 5 measures.

  • Gait analysis [ Time Frame: At 4 years of age ] [ Designated as safety issue: No ]
    The child's walking over ground will be recorded with video cameras, force plates and surface electromyography to determine their walking pattern at 4 years old. This measure will be taken just once when the child is age 4 yr old


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early treatment group
These children will undergo the intervention (i.e., early leg training) shortly after recruitment. Measures will be taken before, during and after the intervention.
Behavioral: Early leg training
Children will engage in ~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity.
Experimental: Delayed treatment group
These children will undergo the intervention (delayed leg training) after a delay of ~3 months, during which outcome measures will be taken so that they can serve as a control for the early treatment group. Their intervention is identical to the Immediate treatment group.
Behavioral: Delayed leg training
The training activity will be exactly the same as the Early leg training group, except that it will occur ~3 months after recruitment.
No Intervention: Control group
These children will be recruited close to the age of 4 years old, and will only undergo gait analysis and GMFM-66 scoring.

Detailed Description:

Children 8 mo to 3 yr old with unilateral perinatal stroke will be randomized into either: 1) Immediate Training, or 2) Delayed Training groups. The Immediate Group will train for 3 mo shortly after recruitment. The Delayed Group will go through the same measurements from the time of recruitment and at 3 mo later (with no training in between) to obtain a 3 mo change score which will serve as a control measure for the Immediate Group. The Delayed Group will also train after the 3 mo delay, when all control measures have been taken. Comparison of the improvements made by children who started training <2 yr old with those >2 yr old will answer the question if training at <2 yr old is better than >2 yr old. Finally, to determine if there are long term effects of this training, we will compare outcomes of these trained children with another group of children with the same injuries but no intensive training (i.e., too old for the training study), when all children turn 4 yr old. Clinical, kinematic and electrophysiological measures will be taken to help us understand not only the efficacy of the treatment, but also the neural mechanisms that might underlie improvements in outcome.

We are measuring outcomes at multiple times because change scores are of most interest. All children change as they age, so it is critical that we compare the change score with and without intervention.

  Eligibility

Ages Eligible for Study:   8 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hemiplegia with confirmation of perinatal stroke through magnetic resonance imaging
  • born near term (> or equal to 36 weeks gestation)
  • current age between 8 months to 3.0 years old; or currently 4 years old (control)
  • no other neurological disorders
  • informed consent from parent or guardian

Exclusion Criteria:

  • central nervous system injury besides the one-sided stroke
  • musculoskeletal problems that limit leg activity
  • cognitive, behavioral or developmental impairments that preclude participation in the protocol
  • unstable epileptic seizures within the last 6 months
  • any contraindications to transcranial magnetic stimulation
  • Botox injection in the legs over the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773369

Contacts
Contact: Donna Livingstone, BScPT 780 492 2258 donna.livingstone@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Donna Livingstone, BScPT    780 492 2258      
Principal Investigator: Jaynie Yang, PhD         
Principal Investigator: Monica Gorassini, PhD         
Sub-Investigator: Francois Roy, PhD         
Sub-Investigator: John Andersen, MD         
Sub-Investigator: Adam Kirton, MD         
Sub-Investigator: Joe Watt, MD         
Sub-Investigator: Jerome Yager, MD         
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Investigators
Principal Investigator: Jaynie Yang, PhD University of Alberta
Principal Investigator: Monica Gorassini, PhD University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01773369     History of Changes
Other Study ID Numbers: Pro00032297
Study First Received: November 30, 2012
Last Updated: January 18, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
cerebral palsy
physical therapy
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014